You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 28, 2024

Loxapine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for loxapine and what is the scope of patent protection?

Loxapine is the generic ingredient in five branded drugs marketed by Alexza Pharms, Teva Branded Pharm, Actavis Labs Ut Inc, Elite Labs Inc, Lannett Co Inc, Rising, and Watson Labs, and is included in eleven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loxapine has two hundred and twenty-seven patent family members in twenty-one countries.

There are eight drug master file entries for loxapine. One supplier is listed for this compound.

Drug Prices for loxapine

See drug prices for loxapine

Recent Clinical Trials for loxapine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 3
Lariboisière-Saint Louis clinical research unitPhase 3
Lee's Pharmaceutical LimitedPhase 3

See all loxapine clinical trials

Medical Subject Heading (MeSH) Categories for loxapine
Anatomical Therapeutic Chemical (ATC) Classes for loxapine

US Patents and Regulatory Information for loxapine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 076762-001 Nov 1, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Elite Labs Inc LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 076868-003 Aug 4, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Teva Branded Pharm LOXITANE loxapine succinate CAPSULE;ORAL 017525-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm LOXITANE loxapine succinate CAPSULE;ORAL 017525-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for loxapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for loxapine

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Ferrer Internacional S.A. Adasuve loxapine EMEA/H/C/002400
Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.
Authorised no no no 2013-02-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for loxapine

Country Patent Number Title Estimated Expiration
Canada 2526475 UNITE DE CHAUFFAGE AUTONOME A ALLUMAGE OPTIQUE OU ELECTRIQUE, ET UNITE D'ADMINISTRATION DE MEDICAMENT UTILISANT CETTE UNITE DE CHAUFFAGE (OPTICALLY IGNITED OR ELECTRICALLY IGNITED SELF-CONTAINED HEATING UNIT AND DRUG-SUPPLY UNIT EMPLOYING SAME) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 02094241 ⤷  Sign Up
Japan 2004536805 ⤷  Sign Up
Australia 2002259241 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 02094239 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for loxapine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1389098 132013902184784 Italy ⤷  Sign Up PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220
1389098 CR 2013 00046 Denmark ⤷  Sign Up PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098 C300609 Netherlands ⤷  Sign Up PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098 SPC/GB13/055 United Kingdom ⤷  Sign Up PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220
1389098 300609 Netherlands ⤷  Sign Up PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.